Last update: 5 January 2018
The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT) under the Ministry of Science and Technology through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
The CDSCO is the national regulatory authority in India that evaluates safety, efficacy and quality of drugs in the country. The DBT, through the RCGM, is responsible for overseeing the development and preclinical evaluation of recombinant biologicals.
The Indian guidelines on ‘similar biologics’ address the regulatory pathway regarding the manufacturing process and quality aspects for ‘similar biologics’ and also the pre-marketing regulatory requirements, including comparability exercise for quality, preclinical and clinical studies and post-marketing regulatory requirements for ‘similar biologics’.
Draft guidelines on ‘similar biologics’ were released for the first time at the BIO Industry Conference on 19 June 2012 in Boston, USA , and the finalized guidelines were implemented from 15 September 2012. These guidelines were then revised and updated, with new guidelines came into effect in August 2016 .
Prior to the introduction of the guidelines on ‘similar biologics’ these products were approved by the RCGM and the CDSCO using an abbreviated version of the pathway applicable to new drugs on a case-by-case basis.
The aim of the introduction of the guidelines was to bring clarity on the subject and lay out a clear regulatory pathway for manufacturers of ‘similar biologics’.
1. Overarching Guidelines
These guidelines cover all 'similar biologic' products:
Guidelines on similar biologics: regulatory requirements for marketing authorization in India, 2016
Effective date: 15 August 2016
The guidelines apply to ‘similar biologics’ that contain well characterized proteins as their active substance, derived through modern biotechnological methods such as use of recombinant DNA technology. The demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a reference biological. The guidelines are applicable for ‘similar biologics’ developed in India or imported into the country.
A ‘similar biologic’ can only be developed against an authorized reference biological that has been approved using a complete data package in India. In cases where the reference biological is not authorized in India, it should have been approved/licensed and marketed in an ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country.
Generally, a reduction in the amount of data required is possible for preclinical and/or clinical components of the development programme by demonstration of comparability of product (similarity to an authorized reference biological) and consistency in the production process, which may vary depending on the characteristics of the already authorized reference biological.
In case the reference biological is used for more than one indication, the efficacy and safety of the ‘similar biologic’ has to be justified and if necessary demonstrated separately for each of the claimed indications unless it meets the conditions set forth in the section ‘Extrapolation of Efficacy and Safety Data to other Indications’.
2. Other Applicable Guidelines
Recombinant DNA Safety Guidelines, 1990
Date: January 1990
Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999
CDSCO guidance for industry, 2008 CT/71108 Version 1.1
Guidelines and Handbook for Institutional Biosafety Committees (IBSCs), 2011
Date: May 2011
To date, India does not have any specific guidelines covering specific types of ‘similar biologic’ products.
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
‘Similar biologics’ approved and marketed in India
EU guidelines for biosimilars
1. GaBI Online - Generics and Biosimilars Initiative. India releases draft ‘similar biologic’ guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 29]. Available from: www.gabionline.net/Guidelines/India-releases-draft-similar-biologic-guidelines
2. GaBI Online - Generics and Biosimilars Initiative. India updates its similar biologics guidelines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Guidelines/India-updates-its-similar-biologics-guidelines
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